The Relationship of single nucleotide polymorphisms in the Interleukin-7 receptor-alpha gene to CD4+ immune recovery in HIV infected patients who begin antiretroviral treatment with HAART
Not Applicable
Completed
- Conditions
- The determinants of immune recovery following institution of Highly Active Antiretroviral Treatment in HIV infected patientsInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12605000495628
- Lead Sponsor
- HMRC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
First antiretroviral regimen composed of HAART as defined by at least three antiretrovirals. Controlled viremia for a period of at least 12 months following commencement of HAART. Controlled viremia is defined as HIV viral load of 500 copies/mL on bDNA testing (versions 2 and 3) and <400 copies/ml measured by RT-PCR assay by 6 months treatment. CD4 cell count <500 at commencement of HAART. Measurement of CD4+ cell count on at least 3 time points, in the 12 months post commencement of HAART.
Exclusion Criteria
Exclude patients treated for HIV seroconversion illness. Exclude patients on immunomodulatory therapy such as IL-2, hydroxyurea or prednisolone or who have received an HIV therapeutic vaccine.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the determinants of immune recovery (namely CD4+ T lymphocyte and HIV viral load). These factors include age, sex, cigarette smoking, Hepatitis C co-infection, CD8+ T-lymphocyte count, nadir and baseline CD4+ T-lymphocyte, baseline HIV viral load, time to undetectable HIV viral load and composition of HAART.[There is no timepoint for this outcome.];Investigating whether interleukin-7 receptor (IL-7Ralpha) polymorphisms and IL-7Ralpha expression may be a determinant of immune recovery.[There is no timepoint for this outcome.]
- Secondary Outcome Measures
Name Time Method There is no secondary outcome.[There is no timepoint for this outcome.]